Clinical Validation of the Use of Blood Biomarkers for the Diagnosis and Monitoring of Alzheimer's Disease

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Alzheimer's disease (AD) has gradually become one of the major global public health issues due to its prevalence, which increases with age and life expectancy, and the economic cost of caring for patients whose cognitive decline progressively leads to loss of functional autonomy. The diagnosis of AD is based on a multidisciplinary approach, involving, among other things, evaluation of the medical history together with clinical symptoms and signs, neuropsychological tests and neuroimaging. The quantification of cerebrospinal fluid (CSF) core biomarkers (amyloid beta peptides \[Ab1-40 and Ab1-42\], total tau \[t-tau\] and its phosphorylated form on threonine 181 \[p-tau(181)\]) has progressively proven utility for the diagnosis of AD and its prodromal forms. CSF biomarkers are now included in international guidelines for the diagnosis of AD in research settings and clinical practice and the Alzheimer's Association appropriate use criteria for the use of lumbar puncture and CSF testing in the diagnosis of AD have been published. Such biochemical diagnostics are currently implemented in many specialized centers around the world. Recent progress in the biological diagnosis of AD is considerable, with the possibility, thanks to ultra-sensitive tests realized notably with the SIMOA technology, of having Ab1-40, Ab1-42, t-tau and p-tau(181) also detectable in the blood using commercial kits. The performance for AD detection has been evaluated by many groups including on retrospective samples. It is now essential to evaluate the interest of blood-based biomarkers of AD, prospectively and in real life condition to confront them with pre-analytical and analytical variabilities. It is also important to position them in relation to CSF analysis and AD management, from risk assessment, diagnosis, to therapeutic strategies.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan.

• Age \>= 18 years old

• CSF AD biomarkers performed for diagnostic purpose in clinical routine practice

• Having given their written and enlightened consent

• Affiliated or beneficiary of the national health insurance

Locations
Other Locations
France
Montpellier University Hospital
RECRUITING
Montpellier
Nîmes University Hospital
RECRUITING
Nîmes
Perpignan Regional Hospital
RECRUITING
Perpignan
Contact Information
Primary
Sylvain Lehmann, MD PhD
s-lehmann@chu-montpellier.fr
0467337123
Backup
Nelly Ginsetet, MSc
n-ginestet@chu-montpellier.fr
0467337124
Time Frame
Start Date: 2022-11-24
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 342
Treatments
Experimental: Prospective multisite clinical trial with consecutive recruitment.
Patients consulting in memory clinics from Montpellier, Nîmes, or Perpignan. CSF AD biomarkers performed for diagnostic purpose in clinical routine practice
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov